Devices

Device Recall BioMend Absorbable Collagen Membrane

Model / Serial
1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Product Description
BioMend Absorbable Collagen Membrane || BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
Manufacturer
Integra LifeSciences Corporation
1 Event
- Recall of Device Recall BioMend Absorbable Collagen Membrane

Manufacturer

Integra LifeSciences Corporation

Manufacturer Address
Integra LifeSciences Corporation, 105 Morgan Ln, Plainsboro NJ 08536-3339
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

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